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510(k) K042629

VARELISA SM ANTIBODIES, MODEL 18296 by Sweden Diagnostics (Germany) GmbH — Product Code LKP

K042629 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Germany) GmbH for the device "VARELISA SM ANTIBODIES, MODEL 18296". The FDA issued a decision of Substantially Equivalent on December 8, 2004. The device falls under product code LKP (Anti-Sm Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Sweden Diagnostics (Germany) GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2004
Date Received
September 27, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Sweden Diagnostics (Germany) GmbH

  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041357 — VARELISA GLIADIN IGG ANTIBODIES (August 2, 2004)
  • K041173 — CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (August 2, 2004)
  • K041174 — CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (July 19, 2004)
  • K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (July 16, 2004)
  • K041040 — VARELISA MPO ANCA, MODEL 17648/17696 (June 16, 2004)

Other clearances for product code LKP

  • K202067 — EliA SmDP-S (July 14, 2021)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)
  • K990625 — AUTOSTAT II ANTI-SM ELISA (April 28, 1999)

FDA data resources